Core Viewpoint - Shanghai Pharmaceuticals announced the approval of its abbreviated new drug application (ANDA) for doxycycline capsules by the U.S. Food and Drug Administration (FDA) [2] Company Summary - Shanghai Pharmaceuticals' subsidiary, Changzhou Pharmaceutical Factory, received notification from the FDA regarding the approval of its ANDA for doxycycline capsules [2]

Core Viewpoint - Shanghai Pharmaceuticals has received FDA approval for its abbreviated new drug application (ANDA) for doxycycline capsules, indicating a significant milestone for the company in the U.S. market [1] Company Summary - Shanghai Pharmaceuticals' subsidiary, Changzhou Pharmaceutical Factory, is the entity that received the FDA notification regarding the approval [1] - The approved doxycycline capsules contain two types of microcapsules: 30mg immediate-release and 10mg delayed-release, targeting inflammatory lesions in adult patients with rosacea [1]

Core Viewpoint - Shanghai Pharmaceuticals (02607.HK) announced a significant equity adjustment involving its actual controller, the Shanghai State-owned Assets Supervision and Administration Commission, which will transfer all shares of Shanghai Industrial (Group) Co., Ltd. to Jinzhong International Holdings Limited [1] Group 1 - Following the equity adjustment, the shareholding of Shanghai Industrial (Group) Co., Ltd. in the company will increase from 25.303% to 38.487% [1] - The equity adjustment will not result in a change of the company's controlling shareholder or actual controller, which will remain the Shanghai State-owned Assets Supervision and Administration Commission [1]

Core Viewpoint - Shanghai Pharmaceuticals has received FDA approval for its abbreviated new drug application (ANDA) for Doxycycline Capsules, marking a significant milestone for the company in the U.S. market [1] Group 1: Company Announcement - Shanghai Pharmaceuticals' subsidiary, Changzhou Pharmaceutical Factory, has been notified by the U.S. FDA regarding the approval of its ANDA for Doxycycline Capsules [1] - The Doxycycline Capsules (40mg) contain two types of micro-pellets: 30mg immediate-release and 10mg delayed-release, primarily used for treating inflammatory lesions of rosacea in adult patients [1] - The original drug was developed by Galderma Laboratories LP and was launched in the U.S. in 2006 [1] Group 2: Financial Investment - As of the date of the announcement, the company has invested approximately RMB 10.83 million in the research and development of this drug [1] - The ANDA application for the drug was submitted to the U.S. FDA in September 2024 and has recently been approved for marketing [1]

Core Viewpoint - Shanghai Pharmaceuticals has received approval from the U.S. FDA for its abbreviated new drug application (ANDA) for Doxycycline Capsules, indicating a significant milestone for the company in the U.S. market [1] Group 1: Company Announcement - Shanghai Pharmaceuticals' subsidiary, Changzhou Pharmaceutical Factory, has successfully obtained FDA approval for Doxycycline Capsules [1] - The drug is primarily used for treating inflammatory lesions of rosacea in adult patients [1] - The original drug was developed by Galderma Laboratories LP and was launched in the U.S. in 2006 [1] Group 2: Financial Investment - The company has invested approximately RMB 10.83 million in research and development for this drug as of the announcement date [1] - The Doxycycline Capsules consist of two types of microcapsules: 30mg immediate-release and 10mg delayed-release [1] Group 3: Regulatory Milestone - The ANDA application for Doxycycline was submitted to the FDA in September 2024 and has now been approved [1]

Core Viewpoint - Shanghai Pharmaceuticals has received approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Doxycycline Capsules, which is significant for expanding its overseas market presence and gaining valuable experience [1] Group 1: Product Information - Doxycycline Capsules (40mg) contain two types of microcapsules: 30mg immediate-release and 10mg delayed-release, primarily used for treating inflammatory lesions of rosacea in adult patients [1] - The original drug was developed by Galderma Laboratories and was launched in the U.S. in 2006 [1] Group 2: Regulatory Approval - The ANDA application for Doxycycline was submitted to the U.S. FDA in September 2024 and has recently been approved for market entry [1] - The company has invested approximately RMB 10.83 million in research and development for this drug as of the announcement date [1] Group 3: Strategic Implications - The approval of Doxycycline Capsules is expected to positively impact the company's efforts to expand into international markets [1] - This achievement is seen as a way to accumulate valuable experience for future endeavors in the pharmaceutical industry [1]

Core Viewpoint - Shanghai Pharmaceuticals has received approval from the Malaysian National Pharmaceutical Regulatory Agency (NPRA) for the marketing of its rivaroxaban tablets, indicating a significant step in expanding its market presence in Malaysia [1] Company Summary - Shanghai Pharmaceuticals announced that its subsidiary, Changzhou Pharmaceutical Factory, has obtained a drug registration certificate for rivaroxaban tablets from the NPRA [1] - The approved rivaroxaban tablets are available in three specifications: 10mg, 15mg, and 20mg [1] Industry Summary - Rivaroxaban is primarily used to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation, as well as for the treatment and prevention of deep vein thrombosis (DVT), treatment of pulmonary embolism (PE), and prevention of venous thromboembolism (VTE) in acutely ill patients [1]

香港交易及結算所有限公司和香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產生或因依賴 該等內容而引致的任何損失承擔任何責任。 上 海 醫 藥 集 團 股 份 有 限 公 司 Shanghai Pharmaceuticals Holding Co., Ltd. * （於中華人民共和國註冊成立的股份有限公司） （股份代碼：02607） 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第 13.10B 條而作出。 茲載列上海醫藥集團股份有限公司（「本公司」）在上海證券交易所網站(http://www.sse.com.cn) 刊登的《上海醫藥集團股份有限公司關於多西環素膠囊獲得美國 FDA 批准文號的公告》、《上 海醫藥集團股份有限公司關於利伐沙班片獲得馬來西亞藥品註冊證書的公告》僅供參閱。 承董事會命 上海醫藥集團股份有限公司 楊秋華 董事長 中國上海，2025 年 10 月 15 日 於本公告日期，本公司的執行董事為楊秋華先生、沈波先生、李永忠先生及董明 先生；非執行董事為張文學先生；以及獨立非執行董事為顧朝陽先生、霍 ...

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告之內容概不負責，對其準 確性或完整性亦不發表任何聲明，並明確表示，概不對因本公告全部或任何部分內容而產 生或因依賴該等內容而引致之任何損失承擔任何責任。 上海醫藥集團股份有限公司 Shanghai Pharmaceuticals Holding Co., Ltd.* ( 於中華人民共和國註冊成立的股份有限公司 ) (股份代碼: 02607) 自願公告 控股股東股權調整 本公告乃由上海醫藥集團股份有限公司（「本公司」）自願刊發。 本次股權調整基本情況 於2025年10月13日，本公司收到實際控制人上海市國有資產監督管理委員會（「上海市國 資委」）出具的《市國資委關於上海實業（集團）有限公司股權調整有關事項的通知》 （滬國資委產權[2025]192號），將上海實業（集團）有限公司（「上實集團」）的全部股 權調整至金鐘國際控股有限公司（「金鐘控股」）（「本次股權調整」）。 本次股權調整後，上海上實（集團）有限公司（「上海上實」）持有及控制的本公司股份 從原有的25.303%增至38.487%，本次股權調整不會導致本公司控股股東和實際控制人發生 變化，本公司的實 ...

证券代码：601607 证券简称：上海医药 编号：临2025-091 上海医药集团股份有限公司 关于利伐沙班片获得马来西亚药品注册证书的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性承担个别及连带责任。 近日，上海医药集团股份有限公司（以下简称"上海医药"或"公司"）下 属常州制药厂有限公司（以下简称"常州制药厂"）生产的利伐沙班片（以下简 称"该药品"）收到马来西亚药品监督管理局（NPRA）颁发的药品注册证书， 该药品获得批准上市。 一、该药品基本情况 药品名称：利伐沙班片 剂型：片剂 规格：10mg、15mg、20mg 注册分类：化学仿制药 申请事项：新产品上市 生产厂家：常州制药厂有限公司 注册证号：10mg: MAL25106012ACZ 利伐沙班片主要用于降低非瓣膜性房颤患者卒中和全身性栓塞的风险；用于 治疗和预防深静脉血栓形成（DVT）；用于治疗肺栓塞（PE）；用于预防急性 病患者静脉血栓栓塞（VTE）等。利伐沙班片最早由 BAYER 和 JANSSEN 联合 研发并于 2011 年在美国上市。2025 年 5 月，常州制 ...